Philips Efficia CMS200 Central Monitoring System

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Efficia Cms200 Central Monitoring System.

Pre-market Notification Details

• Device ID: K160951
• 510k Number: K160951
• Device Name: Philips Efficia CMS200 Central Monitoring System
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD Andover, MA 01810 -1099
• Contact: Mary Kruitwagen
• Correspondent: Mary Kruitwagen; PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD Andover, MA 01810 -1099
• Product Code: MHX
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-05
• Decision Date: 2016-05-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838058309	K160951	000